Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Day Two At ODAC: Reviewing Drugs To Treat T-Cell Lymphoma In A Difficult Class

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA appears to have more concerns with Gloucester's HDAC inhibitor Istodax (romidepsin) than with Allos' Folotyn (pralatrexate).

You may also be interested in...



Gloucester's Istodax Gains FDA Approval Ahead Of New Regulatory Requirements

With FDA's approval a week ahead of the PDUFA date, Gloucester Pharmaceuticals will bring its first product to market, the second HDAC inhibitor approved in cancer.

Gloucester's Istodax Gains FDA Approval Ahead Of New Regulatory Requirements

With FDA's approval a week ahead of the PDUFA date, Gloucester Pharmaceuticals will bring its first product to market, the second HDAC inhibitor approved in cancer.

ODAC Sides With FDA: Evidence For Elderly AML Drugs Can't Stand On Single-Arm Trials

Feasible or not, randomized controlled trials are needed before approval of Genzyme's Clolar and Vion's Onrigin to treat elderly acute myeloid leukemia patients.

Related Content

Topics

UsernamePublicRestriction

Register

LL1129367

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel